The president’s bioethics commission says there is no need to temporarily halt research or to impose new regulations on the controversial new field known as synthetic biology.

In a report being issued Thursday, the Presidential Commission for the Study of Bioethical Issues says that at present the technology — which involves creating novel organisms through the synthesis and manipulation of DNA — poses few risks because it is still in its infancy….

A few key points:

Self-regulation by biologists is a key recommendation. Good idea, but the details will matter a lot. Science, unlike law & medicine, are not licensed professions. That makes meaningful self-regulation harder.

The Report also features a recommendation that scientists in this field receive training in ethics. As an ethics educator, it’s easy for me to cheer for that one. But it’s not immediately clear to me that the kinds of worries that feature prominently in criticisms of synthetic biology — ecological damage, bio-terrorism, etc. — are ones that can meaningfully be dealt with this way.

It’s not surprising that opponents of syn-bio have been harshly critical of the Report. On the other hand, the lavish praise heaped on the report by BIO (Biotechnology Industry Organization) worries me somewhat…it makes me worry that the recommendations for regulatory oversight are not as challenging to industry as they might be. In the abstract, I would have liked to see a set of recommendations that BIO saw as tough but fair, instead of as “reasonable, well balanced and insightful.”

The Scientist spoke with chair Amy Gutmann, president of the University of Pennsylvania, about the commission’s conclusions that, despite the potential risks of creating synthetic organisms, the research should be allowed to continue.

The interview provides a good primer on the ethical issues. I’ll just point out one interesting bit. Near the start, Gutmann says:

Given that it’s a very new field, there is an opportunity to ensure that as it develops, its benefits for the public are maximized and its risk, correspondingly, minimized.

Without the benefits, no risks are worth taking. So we have to begin with the benefits…. [emphasis added]

That sounds reasonable enough, except that — depending on how narrowly you read the word “benefits” — it seems to cut off the possibility of the pursuit of knowledge for its own sake.

Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry.

The new position was declared in a friend-of-the-court brief filed by the Department of Justice late Friday in a case involving two human genes linked to breast and ovarian cancer….

In essence, the new position is based on the idea that genes are naturally-occurring, and hence not inventions in the sense required by patent law.

However, the government suggested such a change would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops or gene therapies, could still be patented. Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina, who headed a government advisory task force on gene patents, called the government’s brief “a bit of a landmark, kind of a line in the sand.”

Interestingly (or at least interestingly to philosophers and law professors), this is roughly in line with a Lockean theory of property, according to which something in nature can be claimed as property only once one has ‘mixed one’s labour’ with it.

Benighted European politicians seem determined to discourage certain innovations in food technology even when the rest of the world stands as living—and eating—proof of their safety.

The European Parliament called in July for a ban on marketing foods derived from cloned animals and their offspring, and on Oct. 18 the European Commission proposed sweeping, temporary bans on animal cloning for food production. The proposal encompasses the use of cloned farm animals and the marketing of food from clones, and also create a system to trace imported genetic material such as semen and cloned embryos.

These proposals conflict with the expert opinions of the European Food Safety Authority, which has said repeatedly that with respect to food safety, there is no difference between milk and meat from conventionally bred animals and those obtained from clones and their offspring….

I’ll only add that the vast majority of people simply have no idea what a clone really is. And that’s a shame. Because whether the topic is human cloning or cloning animals for food, a little misunderstanding goes a long way. And it really doesn’t take much understanding to correct quite a few ethical errors. I’m not a scientist, but every year in my Critical Thinking class I spend about 120 seconds teaching my students the basics of the laboratory cloning process. That’s all it takes.

If you think this topic is important, do yourself a favour and at least read up on the basics. To that end, here’s the Wikipedia page on cloning.

The Twittersphere and anti-biotech blogosphere have recently seen a flurry of joyful announcements of financial trouble at biotech giant Monsanto. Rumours of the companies death are, as they say, greatly exaggerated, but it is true that the company has suffered a bit of a downturn.

As recently as late December, Monsanto was named “company of the year” by Forbes magazine. Last week, the company earned a different accolade from Jim Cramer, the television stock market commentator. “This may be the worst stock of 2010,” he proclaimed.

Monsanto, the giant of agricultural biotechnology, has been buffeted by setbacks this year that have prompted analysts to question whether its winning streak from creating ever more expensive genetically engineered crops is coming to an end.

The company’s stock, which rose steadily over several years to peak at around $145 a share in mid-2008, closed Monday at $47.77, having fallen about 42 percent since the beginning of the year….

The problem, very roughly, is that some of Monsanto’s (genetically-modified) seeds have underperformed, and failed to meet the expectations of their customers — i.e., farmers. According to a company VP cited in the NYT story:

“Farmers clearly gave us some feedback that we have made adjustments from.”

I’m no expert on the seed industry, but that quote — and the idea of a biotech company needing to make immediate adjustments based on customer feedback — really gave me pause. The time-lines for getting a new genetic manipulation to market are relatively long. (Can anyone give me a specific time-line?) In most industries, consumers give feedback and expect improvements soon. What are the consequences of that mismatch between the long time-lines of scientific research, the short-term expectations of customers, and the perhaps even shorter-term expectations of investors?

Industry forecasts indicate that Canadians will soon face a marketing avalanche to persuade them to purchase personal genetic test kits. But while American officials are moving to regulate do-it-yourself genetic testing kits because of concerns that results may be erroneous or may prompt patients to alter their medications or make other unhealthy choices, Health Canada says it is open season for companies hunting for Canadian sales.

Many have expressed worries about direct-to-consumer genetic testing. I’ve blogged about some of those worries, including here:

But it’s not at all clear that the permissive attitude of Health Canada is going to result in an avalanche of tests being made available in Canada. A lack of regulation can actually mean a lack of certainty for companies, and a lack of certainty makes for bad investments. I personally spoke to one American biotech executive a couple of years ago who cited Canada’s relative lack of regulations as one reason why her company was hesitant to invest here.

Biotech Ethics BLOG

This blog is about ethical issues in the biotechnology industry. That includes all 3 main areas of that industry: health biotech, food biotech, and industrial biotech. (The last two are particularly important, and don't get enough attention.)

Unlike my Business Ethics Blog, this one will focus on aggregating information, rather than offering much commentary.